Method of providing a signal to alert an ostomate of an imminent leakage of stoma fluids

ABSTRACT

A method of providing a signal to alert an ostomate of an imminent leakage of stoma fluids relative to their ostomy device is disclosed.

SUMMARY

The disclosure relates to an ostomy appliance as defined in the appendedclaims. Particularly, the disclosure relates to such an appliancecapable of predicting, or predetermining, leakage or potential leakageof stomal fluids and of giving a user or health care professional awarning in time to react before leakage occurs.

BACKGROUND

Leakage of stomal fluids continues to be a primary subject of concernfor ostomists, often being referred to as a major contributor to reducedquality-of-life for this group of people.

However, even when leakage does not occur, all ostomy applianceseventually need to be changed. A normal maximum wear time for ostomyappliances is usually around 4-5 days. Over such a period of time, theadhesive interface with the skin is gradually weakened and the adhesiveinterface eventually fails. The reasons for this failure includemoisture uptake from the skin to the adhesive material and the exposureof the adhesive material to the harsh stomal fluids.

One major issue in regards to leakage is that it often occursunexpectedly and without any prior warning signals. Experience showsthat leakage incidents can be caused by several factors, includingfactors which are unique to the individual user, such as the stoma type,location of stoma, peristomal skin topography and general healthcondition of the user. Most often, a leakage incident means that stomalfluids enter into a space between the proximal surface of the carriersheet and user's skin. This leads to destruction and/or weakening of theadhesive material carrying the weight of the appliance, in many casesvery rapidly and only detectable for the user once the failure hasoccurred and the damage done.

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates a cross-sectional view of one embodiment of an ostomyappliance;

FIG. 2 illustrates a cross-sectional view of one embodiment of an ostomyappliance;

FIG. 3 illustrates a top view of one embodiment of an ostomy appliance;and

FIG. 4 illustrates a top view of one embodiment of an ostomy appliance.

DETAILED DESCRIPTION

In this disclosure, whenever referring to proximal surface of a deviceor part of a device, the referral is to the skin-facing surface, whenthe wafer or ostomy appliance is worn by a user. Likewise, wheneverreferring to the distal surface of a device or part of a device, thereferral is to the surface facing away from the skin, when the wafer orostomy appliance is worn by a user. In other words, the proximal surfaceis the surface closest to the user, when the wafer is fitted on a userand the distal surface is the opposite surface—the surface furthest awayfrom the user in use.

In this disclosure, “peristomal skin surface” is intended to mean aportion of an ostomist's skin surface immediately adjacent to and/orsurrounding the ostomy.

In this disclosure, “dissipate” and “dissipation” is intended to referto a gradual, stepwise or constant dissolving or breakdown process of amaterial. In other words, the depletion of a material over time, eitherin stages of different intensity or at a relatively constant rate.

In this disclosure, the wordings “ostomy” and “stoma” are usedinterchangeably without any intent to imply different meanings.

In this disclosure, “stomal fluids” is intended to mean output from astoma, being faeces and/or urine in a more or less viscous form ormucins secreted from the epithelial layer of the alimentary canal. Inthe case of a colostomy, the output may be quite solid, whereas anileostomy may produce more liquid output. The output may containdigestive juices with enzymes and other components that can beaggressive to the skin and therefor can cause maceration of skinsubjected to the output as well as to the materials of the ostomyappliance, including the adhesive material.

In this disclosure, “sheet” is intended to mean a thin, flat piece ofmaterial.

In this disclosure, “swellable” is intended to mean the capability of amaterial to take up moisture or liquid/fluid leading to an increase inthe volume of the material. The volume increase can be substantial, suchas to be visible to the naked eye without problem or by being easilyfelt by a user of the ostomy appliance.

Embodiments provide an ostomy appliance comprising a carrier sheethaving an adhesive material on a proximal surface for attachment to theskin surface of a user, the appliance further comprising a secondmaterial on a distal surface of the carrier sheet and a signal generatoradapted to provide an indicator signal in response to dissipation of thesecond material caused by exposure to stomal fluids acting on a side ofthe carrier sheet facing away from the skin of user. Embodiments furtherprovide such an appliance comprising a collecting bag for collectingstomal fluids. Embodiments further provide such an appliance wherein thecollecting bag is permanently or detachably connected to the carriersheet.

Embodiments provide an ostomy appliance that is capable of providing anindicator signal to the user warning him/her of an imminent leakageincident or the potential therefor. Unlike existing solutions, theostomy appliance of the present disclosure provides a solution whichreacts to the breakdown or depletion of a second material that is notcritical to maintaining the function of the appliance.

The breakdown of such non-critical, second material occurs as a resultof the second material being exposed to stomal fluids. The breakdown ofthe second material happens on the side of the carrier sheet facing awayfrom the user. A preferred level of breakdown of the second material, atwhich the indicator signal is set off, can be selected and made toreflect or mimic a breakdown-level of the first adhesive material, atwhich the breakdown of the first adhesive material is not yet criticalfor the correct functioning of the appliance. In other words: accordingto the present disclosure a warning in due time before the occurrenceleakage. As such, the preferred breakdown-level of the second materialcan be set to correspond to a level of breakdown of the load-carryingfirst adhesive material.

The breakdown-levels of the first adhesive material and the secondmaterial can be based on experience and/or test generated data. One wayof obtaining such data is by testing and correlating the breakdown-timeand/or breakdown—manner of adhesive material of the type disposed on theproximal surface of the carrier sheet with the breakdown-time and/orbreakdown—manner of the second material of the type disposed on thedistal surface of the carrier sheet.

Based on such data, a preferred breakdown-level of the second materialon the distal surface of the carrier sheet can be chosen such that itcorresponds to certain, not yet critical breakdown-level of the firstadhesive material. As the signal generator is adapted to set off anindicator signal when the dissipation of the second material has reacheda preferred level, the user is provided with a warning in time to changeto a new appliance before the old appliance fails and leakage occurs.The present disclosure thus relates to an ostomy appliance which iscapable of predicting, or predetermining, leakage or potential leakageand warn a user in time to react before the leakage occurs.

FIG. 1 is a cross-sectional view illustrating one embodiment of anostomy appliance 10 of the present disclosure comprising a carrier sheet12, a first adhesive material 18, a second material 20 and a signalgenerator 22. The carrier sheet 12 has a proximal surface 16 and adistal surface 17. The first adhesive material 18 is disposed on theproximal surface 16 of the carrier sheet 12. The second material 20 isdisposed at least on a portion of the distal surface 17 of the carriersheet 12. A through-going hole 13 extends from the proximal surface 16of the carrier sheet 12 to the distal surface 17 of the carrier sheet12. A first zone 26 is configured radially inward of an attachmentbetween the collecting bag 14 and the distal surface 17 of the carriersheet 12 in relation to the through-going hole 13, and a second zone 28is configured radially outward of the attachment. In embodiments, thesecond material 20 and the signal generator 22 are located in the firstzone 26. Thereby, stomal fluid exiting the stoma is prevented fromcoming into contact with the distal surface 17 of the carrier sheet 12in the second zone 28. In embodiments, no portion of the second material20 is provided radially outward of the attachment between the collectingbag 14 and the distal surface 17 of the carrier sheet 12, i.e. noportion of the second material 20 is located in the second zone 28.Embodiments ensure that only the first zone 26 can be exposed to stomalfluids, thereby providing for the flow of stomal fluids to be directedto the second material 20.

FIG. 2 is a cross-sectional view illustrating one embodiment of anostomy appliance 10 of the present disclosure in a use-situation whereit is located on the skin surface 23 and around the stoma 24 of a user.

FIG. 3 is a top view of one embodiment of the ostomy appliance 10 of thepresent disclosure with the collection bag 14 left out for illustrationpurposes. The view illustrates the appliance 10 with the distal surface17 of the carrier sheet 12 facing the viewer. The embodiment shows thesignal generator 22 in dotted line, to illustrate that in a prior-to-usecondition of the appliance 10, as shown in FIG. 3 , the signal generator22 is covered by the second material 20. In the embodiment of FIG. 3 ,the signal generator 22 is illustrated as being applied in a ring shape.

In one embodiment, the signal generator 22 is provided between thedistal surface 17 of the carrier sheet 12 and the second material 20. Inone embodiment, the second material 20 is configured to enclose thesignal generator 22 on three sides while the distal surface 17 of thecarrier sheet 12 encloses the signal generator 22 on a fourth side. Inone embodiment, the second material 20 is configured to cover the signalgenerator 22 on one side. In one embodiment, the second material 20 isconfigured to cover the signal generator 22 on two sides. In oneembodiment, the second material 20 is disposed directly onto the distalsurface 17 of the carrier sheet 12. In one embodiment, the signalgenerator 22 is provided between distal surface 17 of the carrier sheet12 and the second material 20, such that less than an entirety of thesecond material 20 is disposed directly on the distal surface 17 of thecarrier sheet 12. In one embodiment, the signal generator 22 is attachedto the distal surface of the carrier sheet 12.

FIG. 4 schematically illustrates a top view of one embodiment, in whichthe signal generator 22 comprises a plurality of dot-formed attachmentportions 32 on the distal surface 17 of the carrier sheet 12. In FIG. 4, the collecting bag 14 and the second material 20 are left out forillustration purposes. In one embodiment, the plurality of dot-formedattachment portions 32 locates in a first zone 26 radially inward of anattachment 30 of the collecting bag 14 to the distal surface 17 of thecarrier sheet 12, when seen in relation to a central longitudinal axis34 extending through the through-going hole 13. In one embodiment, eachof the dot-formed attachment portions 32 is individually connected to aprimary portion 36 of the signal generator 22. In one embodiment, theindividual connections 38 between the dot-formed attachment portions 32and the primary portion 36 takes a shape similar to a treetop whereinthe dot-formed attachment portions 32 are the branches and the primaryportion 36 the trunk of the tree. Alternatively, the individualconnections between the dot-formed attachment portions and the primaryportion forms a shape comparable to an open palm of a hand and forearm.In one embodiment, the signal generator 22 is located on the distalsurface 17 such that it extends radially from the first zone 26 to thesecond zone 28 and under the collection bag attachment 30. Inembodiments, two or more signal generators 22 are provided. Thereby,leakage can be detected in a plurality of locations providing secure andfast detection.

The different distributions of the second material 20 in relation to thesignal generator 22 according to the several embodiments provideadditional options for selecting a predetermined breakdown-level of thesecond material 20, at which the signal generator 22 is adapted to setoff an indication signal to warn the user about potential, or upcoming,leakage.

In one embodiment, a portion of the second material 20 being radiallyclosest to a central, longitudinal axis extending through thethrough-going hole 13, is adapted to be flush (at level or in line) witha periphery of the through-going hole 13 in the carrier sheet 12. In oneembodiment, the portion of the second material 20 being radially closestto the central, longitudinal axis extending through the through-goinghole 13, is adapted to be offset from the periphery of the through-goinghole 13 in the carrier sheet 12 in relation to the central, longitudinalaxis. Effects of offsetting the radially innermost portion of the secondmaterial 20 include the provision of an ostomy appliance that allows tocustomize the size and shape of the through-going hole 13 in order toreceive an individual, unique stoma.

In one embodiment, the ostomy appliance 10 includes a collecting bag 14attached to the distal surface 17 of the carrier sheet 12 at attachment30. In one embodiment, the collecting bag 14 is detachably attached tothe distal surface 17 of the carrier sheet 12. In one embodiment, afirst coupling half (not shown) is arranged on the collecting bag 14 anda second coupling half (not shown) is arranged on the distal surface 17of the carrier sheet 12. In one embodiment, the first coupling halfcomprises an adhesive ring and the second coupling half comprises anadhesive or non-adhesive ring-formed flange adapted to receive theadhesive ring of the first coupling half. Other types of couplingsystems conventional to ostomy appliances are contemplated to be equallyapplicable and acceptable with an ostomy appliance according to thepresent disclosure.

The collecting bag 14 comprises a front wall on the distal side and arear wall on the proximal side. These walls are made of gas- and liquidimpermeable foil-material (for example of polyethylene (PE),polyvinyl-chloride (PVC) or ethylene-vinyl-acetate (EVA)) that is weldedaround the edges or the rim so as to form a pouch defining a wastecollection chamber. The bag may be welded only partly around the rim sothat an opening for emptying the bag can be provided at the bottom ofthe bag. In that case, the bag may be provided with means for closingthat opening. The waste inlet opening is provided in the rear wall andplaced in the upper part of the collecting bag so that when a userstands up, the waste inlet opening will be above the midline of thecollecting bag. This leaves a larger collecting volume below the wasteinlet opening. Thus, a top of the collecting bag is defined as theportion of the bag closest to the waste inlet opening, and a bottom isdefined as the opposite portion of the bag.

Prior to application of the ostomy appliance to the skin, a protectiverelease liner (not shown) can cover the proximal surface of the firstadhesive material in order to ensure that the properties of the adhesivematerial are preserved and that the adhesive surface is not laid openuntil just before use. Suitable release liners include a siliconized orfluorinated release liner, such as a siliconized or fluorinated craftpaper, polyethylene, polypropylene or polyethylene terephthalate film.In one embodiment, the release liner is a siliconized polyethylene film,such as medium density polyethylene from the company Huhtamaki.

In one embodiment, the through-going hole 13 is a relatively smallopening allowing for individual customization according to the size andshape of the user's unique stoma. In one embodiment, the through-goinghole 13 is a relatively larger opening being provided at manufacture. Inanother embodiment, a customized size and shape of the through-goinghole 13 to fit an individual's stoma is provided at manufacture.

In embodiments, the carrier sheet 12 comprises a blown film based on oneor more Ethylene Vinyl Acetate (EVA) materials, one or moreThermoplastic Polyurethane Elastomer (TPU) based materials and one ormore Polyethylene (PE) materials or blends thereof.

In embodiments, the first adhesive material 18 can comprisepolyisobutylene, styrene-isoprene-styrene and hydrocolloids such as, butnot limited to, the types of adhesives disclosed in WO 99/11302.

In embodiments, the first adhesive material 18 is a pressure sensitiveadhesive composition, such as one described in European patentEP1541180, comprising a rubbery elastomeric base and one or more watersoluble or water swellable hydrocolloids, the adhesive compositioncomprising a substantially homogeneous mixture of 25-60% of one or morepolyisobutylenes, 3-35% of one or more styrene copolymers, and 20-60% ofone or more hydrocolloids, wherein the percentage by weight of one ormore polyisobutylenes and one or more styrene copolymers and one or morehydrocolloids add up to 100% by weight of the adhesive composition.Another suitable first adhesive material is described in WO2009/006901.

In embodiments, the second material 20 is a material that is configuredto dissipate in response to being exposed to stomal fluids. Inembodiments, the second material 20 is an adhesive material. Inembodiments, the adhesive material of the second material 20 comprisesone or more of the adhesive types of the first adhesive material 18 asdescribed above. Handling fewer different types of materials, such asadhesive materials, during manufacture of the ostomy appliance, ensureslower complexity and lower costs of the manufacturing procedures.

In one embodiment, the second material 20 is an adhesive material beingidentical to the first adhesive material 18. This ensures low complexityin manufacturing and is envisioned to provide direct correlation betweenbreakdown-levels of the first adhesive material 18 and of the secondadhesive material 20. In other words, the rate of breakdown of thesecond adhesive material 20 will be the same as the rate of breakdown ofthe first adhesive material 18 when subjected to the same stomal fluids.

The factors influencing when the signal generator 22 sets off theindicator signal will therefore be reduced to a question of dimensionsand how the second adhesive material and the signal generator 22 areconfigured in relation to each other.

A preferred level of security, in terms of how soon before the firstadhesive material 18 fails an indication signal is desired, cantherefore be straightforwardly selected by dimensioning and configuringthe second adhesive material 20 in relation to the signal generator 22according to the different embodiments of this disclosure.

In one embodiment, the second material 20 comprises a material thatdissipates very easily when subjected to fluids, including stomalfluids. In one embodiment, the second material 20 has a seconddissipation rate when subjected to stomal fluids that is substantiallyhigher than a first dissipation rate of the first adhesive material 18,such as a factor of ten or higher.

In embodiments, the second material 20 is provided such as to form apolymer matrix composition. In embodiments, the polymer matrixcomposition is soluble in liquids and/fluids, such as stomal fluids andwater. The solubility of the polymer matrix, or rate of dissipation, canbe selected in accordance with the principles presented above.

In embodiments, the signal generator 22 is provided as a substance orcompound of two or more substances. In embodiments, the substance, orsubstances, forming the signal generator 22 is located on the distalsurface 17 of the carrier sheet 12 and proximal to the polymer matrixcomposition of the second material 20. In one embodiment, the substance,or substances, forming the signal generator 22 is embedded, i.e.enclosed in the surrounding mass of the polymer matrix composition ofthe second material 20.

In one embodiment, the substance of the signal generator 22 comprises acolorant. The colorant substance is dissolvable in liquids and/orfluids, such as stomal fluids reaching the colorant substance. Thereby,the colorant substance will color the stomal output and the coloredoutput dropping into the collecting bag provides the indicator signal,instructing the user to change to a new appliance. Examples of suitablecolorants include, but are not limited to, food colors and other solubledyes.

Alternatively, or additionally, the signal generator 22 is adapted toprovide the indicator signal as a change in the visual characteristicsof the second material 20 or of the distal surface 17 of the carriersheet 12. This can include providing the signal generator 22 as acolorant that dissolves into the polymer matrix of the second material20, or dissolves into the distal surface 17 of the carrier sheet 12 whensubjected to liquids and/or fluids.

In one embodiment, the signal generator 22 comprises a sticker indicator40 (illustrated in FIG. 4 ). In one embodiment, the sticker indicator 40contains a substance that changes color when subjected to liquids and/orfluids. In one embodiment, the sticker indicator 40 is provided on aportion of the distal surface 17 of the carrier sheet 12 located in asecond zone 28 radially outward of an attachment 30 of the collectingbag 14 to the distal surface 17 of the carrier sheet 12, seen inrelation to a central longitudinal axis 34 extending through thethrough-going hole.

Alternatively, or additionally, the signal generator 22 is adapted toprovide the indicator signal as a change in the tactile characteristicsof the second material 20 or of the distal surface 17 of the carriersheet 12. This can include providing a signal generator 22 substance asa swellable material capable of taking up moisture from the stomaloutput and engaging with the polymer matrix of the second material 20,or with the distal surface 17 of the carrier sheet 12. When theswellable material takes up moisture from the stomal fluids it increasesin volume. The increased volume of the material provides an easilydetectable tactile indication signal that an upcoming change ofappliance is near. Particularly, it provides the user or health careprofessional with an option of detecting the indicator signal bypalpating the portion of the appliance in the peristomal area. Suitableswellable materials include hydrocolloids such as CMC and pectin.

These options facilitate detection of the indicator signal at more thanone location, including at, or near, the stoma, on the carrier sheet 12and in the collecting bag. The options can be applied individually orfurther advantageously in combinations.

In embodiments, the substance of the signal generator 22 is adapted totake up moisture and turn into a gel-like material when subjected toliquids and/or fluids. The material can be provided in dry form atmanufacture and then take up moisture and turn into the gel-likematerial when subjected to stomal fluids. The gel-like material can beadapted to increase in volume or to alternatively substantially maintainits volume, even after moisture uptake. The gel-like material providesanother option for producing a tactilely (and visually) indicator signalthat is easily detectable for the user. In one embodiment, the substanceof the signal generator 22 is provided in a ring shape surrounding thethrough-going hole 13.

In embodiments, the signal generator 22 is adapted to provide anindicator signal when the dissipation of the second material 20 reachesa pre-defined threshold value, or level. The pre-defined thresholdvalue, or level, can be selected in accordance with the principlespresented above.

In one embodiment, the signal generator 22 comprises an electroniccomponent. In one embodiment, the electronic component is adapted to bepowered by a battery. In one embodiment, the electronic component isadapted to be powered by a piezoelectric element.

In one embodiment, the signal generator 22 comprises an indicator signalemitter. In one embodiment, the signal generator 22 is adapted toprovide the indicator signal as a sound signal. In one embodiment, thesignal generator 22 is adapted to provide the indicator signal as anoptical signal. In one embodiment, the signal generator 22 is adapted toprovide the indicator signal as a radio signal. In embodiments, thesignal generator 22 comprises an NFC (Near Field Communication) unit. Inembodiments, the NFC unit is adapted to communicate with a portabledevice, such as, but not limited to, a smartphone, a smartwatch or atablet and configured to communicate the signal indicating upcomingchange of appliance to the user via the portable device.

In one embodiment, the signal generator 22 includes a sensor. In oneembodiment, the sensor is sensible to liquids and/or fluids. In oneembodiment, the sensor is sensible to inflow of light to the sensor. Inone embodiment, the sensor is sensible to the presence of material on asurface of the sensor. In one embodiment, the sensor is sensible topressure. In one embodiment, the sensor is sensible to changes inrelative humidity.

Embodiments provide an ostomy appliance comprising a signal generatoradapted to give a user or a health care professional a warning in timeto change the appliance before leakage occurs by predetermining leakageor potential leakage of stomal fluids. A plurality of suitable optionsfor providing a signal generator according to the present disclosurehave been disclosed. Embodiments further provide ostomists with animproved possibility of avoiding troublesome and embarrassing leakageincidents, leading to an improved feeling of security and increasedquality-of-life wearing an ostomy appliance as presented. Embodimentsfurther provide an ostomy appliance comprising a leakage warning signalgenerator provided on a distal surface of the base plate, i.e. on theside of the base plate facing away from the user's skin surface, therebyfacing away from the surface of the base plate where leakage normallyoccurs. This provides for an ostomy appliance having a predictiveleakage indicator in contrast to a reactive leakage indicator, which inturn saves the user of the burden of leakage occurring unexpectedly.

Embodiments, and features of the various exemplary embodiments describedin this application, may be combined with each other (“mixed andmatched”), unless specifically noted otherwise.

What is claimed is:
 1. A method of providing a signal to alert an ostomate of an imminent leakage of stoma fluids relative to their ostomy device, the method comprising: providing an ostomy appliance comprising a carrier sheet having a first adhesive deposited on a proximal side of the carrier sheet and adapted to secure the ostomy appliance to skin of the ostomate, a second adhesive deposited on a distal side of the carrier sheet, a hole formed through the first adhesive and the carrier sheet and the second adhesive with the hole adapted to fit the ostomy appliance around a stoma of the ostomate, a connector coupling disposed on the distal side of the carrier sheet and adapted to secure an ostomy bag around the hole, and a signal generator located on the distal side of the carrier sheet and in contact with the second adhesive; determining a breakdown level of the first adhesive that is indicative of at least one of a reduction in load-carrying of the first adhesive and a reduction in liquid barrier of the first adhesive due to contact of the first adhesive with stomal output; correlating a breakdown of the second adhesive to the breakdown level of the first adhesive; locating a reading portion of the signal generator between the hole and the connector coupling and locating an indicator of the signal generator between connector coupling and an outermost perimeter of the carrier sheet; and providing a warning to the ostomate with the indicator of the signal generator of a potential leakage of the stomal output relative to the first adhesive based on the breakdown of the second adhesive due to the stomal output sensed by the reading portion of the signal generator between the hole and the connector coupling.
 2. The method of claim 1, further comprising: locating the reading portion of the signal generator on the distal side of the carrier sheet radially inside of the connector coupling and exposed to the stomal output during use and locating the indicator of the signal generator between radially outside of the connector coupling.
 3. The method of claim 1, further comprising: locating the reading portion of the signal generator between the carrier sheet and the second adhesive.
 4. The method of claim 1, further comprising: locating the signal generator on the distal side of the carrier sheet and completely covering the reading portion of the signal generator with the second adhesive.
 5. The method of claim 1, further comprising: attaching the reading portion of the signal generator to a distal surface of the carrier sheet and between the carrier sheet and the second adhesive.
 6. The method of claim 1, further comprising: providing a visual change to the indicator as the warning to the ostomate of the potential leakage of the stomal output relative to the first adhesive.
 7. The method of claim 1, further comprising: providing a tactile change to the indicator as the warning to the ostomate of the potential leakage of the stomal output relative to the first adhesive.
 8. The method of claim 1, further comprising: providing a sound from the indicator as the warning to the ostomate of the potential leakage of the stomal output relative to the first adhesive.
 9. The method of claim 1, wherein the connector coupling further comprises a coupling flange welded to the ostomy appliance and adapted to removably attach with a mating flange on the ostomy bag.
 10. The method of claim 1, wherein the connector coupling further comprises an adhesive coupling ring adapted to removably attach with a second-half adhesive coupling ring applied to the ostomy bag.
 11. The method of claim 1, further comprising: locating the reading portion of the signal generator between the hole and the connector coupling for exposure to the stomal output collected inside of the ostomy bag during use.
 12. The method of claim 1, further comprising: locating the indicator of the signal generator away from the stomal output to be collected inside of the ostomy bag during use.
 13. The method of claim 1, further comprising: formulating the second adhesive to breakdown due to the stomal output before the first adhesive breaks down from the stomal output.
 14. The method of claim 1, further comprising: measuring the breakdown level of the first adhesive indicating reduced liquid barrier properties of the first adhesive when in contact with the stomal output; and providing the warning to the ostomate with the indicator of the signal generator, during use, before the stomal output leaks between the first adhesive and the skin of the ostomate based on the measuring of the breakdown level of the first adhesive. 